Daytime Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, nasal congestion, fever, and cough due to minor throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every four hours. It is imperative that the softgels are swallowed whole; they must not be crushed, chewed, or dissolved prior to ingestion.

This product is not intended for use in children under 12 years of age.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure accurate dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

• Exceeding the recommended dosage is contraindicated to prevent potential adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen is also associated with the risk of severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if they experience a sore throat that is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

It is critical to adhere to the recommended dosage, as exceeding this can lead to liver damage. In the event of an overdose, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin.

While using this product, it is crucial not to exceed the recommended dosage.

Patients should be instructed to stop taking the product and contact their doctor if any of the following occur: pain, cough, or nasal congestion worsens or lasts longer than seven days; nervousness, dizziness, or sleeplessness develops; fever worsens or persists for more than three days; redness or swelling is observed; new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical assistance is crucial; patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients may experience severe skin reactions associated with acetaminophen, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, it is imperative to discontinue use and seek medical attention immediately.

Participants in clinical trials and postmarketing experiences have indicated that patients should stop using the product and consult a healthcare provider if pain, cough, or nasal congestion worsens or persists beyond seven days; if nervousness, dizziness, or sleeplessness occurs; if fever intensifies or lasts more than three days; if redness or swelling is observed; if new symptoms develop; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Patients with pre-existing conditions such as liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or those experiencing trouble urinating due to an enlarged prostate gland should consult a healthcare professional prior to use. Additionally, individuals with a persistent or chronic cough, particularly those related to smoking, asthma, or emphysema, or those with a cough accompanied by excessive phlegm, should also seek medical advice before using this product.

Furthermore, patients taking the anticoagulant warfarin are advised to consult a doctor or pharmacist before using acetaminophen, as interactions may occur.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 4 doses within a 24-hour period.

Healthcare professionals should be aware of the importance of quick medical attention in cases of overdose, as it is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. Monitoring of liver function is recommended, particularly in those with compromised liver function, to prevent potential hepatotoxicity.

Patients should be aware that taking more than the recommended dose can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Exceeding the recommended dosage of the medication can lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial, as the onset of symptoms may not be immediately apparent.

Both adults and children are at risk, and it is essential to seek quick medical attention even in the absence of noticeable signs or symptoms. Early recognition and management of an overdose can significantly improve outcomes and mitigate potential complications.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, they should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. If fever worsens or lasts more than three days, or if redness or swelling occurs, patients should also be advised to seek medical attention. They should be made aware that new symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, may indicate a serious condition, warranting immediate medical consultation.

While using this product, patients must be cautioned not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, patients should be advised to consult a doctor if they have a cough that produces excessive phlegm (mucus) or if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to maintain the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Daytime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)